Swedish Match USA, Inc., MRTP Applications
On October 22, 2019, the FDA issued modified risk orders to Swedish Match USA, Inc. (previously known as Swedish Match North America, Inc.), for the following snus smokeless tobacco products:
- General Loose
- General Dry Mint Portion Original Mini
- General Portion Original Large
- General Classic Blend Portion White Large-12ct
- General Mint Portion White Large
- General Nordic Mint Portion White Large-12ct
- General Portion White Large
- General Wintergreen Portion White Large
See the Modified Risk Orders webpage for order letters and decision summaries relevant to these actions.
Please sign up to receive email alerts when materials from any MRTP applications under scientific review have been posted. The latest set of application materials from Swedish Match USA, Inc. were made available on February 1, 2019.
Materials and Related Documents
Temporary Compliance Waiver: The linked files may not be fully accessible to readers using assistive technology. We regret any inconvenience that this may cause. In the event you are unable to read these documents or portions thereof, please email AskCTP@fda.hhs.gov or call 1-877-287-1373.
Additional materials related to the actions include:
- FDA Decision Summary (PDF – 5 MB) – posted December 14, 2016
- FDA Response Letter (PDF – 65 KB) – posted December 14, 2016
- FDA Denial Letters (.zip – 282 KB) – posted December 14, 2016
- Summary of Applications (PDF – 32 MB) (posted August 27, 2014; updated January 16, 2019)
- FDA initially redacted certain harmful and potentially harmful constituents (HPHC) information on pp. 517-544 (internal document pagination), which were later made publicly available. The current version reflects the removal of these redactions.
- Swedish Match North America, Inc. MRTP Applications (zip*, 813 files, 1.7 GB) – posted August 27, 2014
- We have numbered the files to help you navigate through the materials in a logical order. For example, start with "01 application narrative summary_Redacted.pdf," proceed to "02 appendix-2a-iom-2012_Redacted.pdf," etc.
- Amendments to the Applications
- Amendments to Swedish Match North America, Inc. MRTP Applications Received After Filing, (.zip – 1.14 GB) posted July 31, 2015
- September 17, 2018 Amendment: Response to FDA's December 14, 2016 Letter (.zip 65 MB) posted October 10, 2018
- November 28, 2018 Amendment: Response to October 24, 2018, FDA Advice and Information Request Letter (.zip – 114 MB) posted December 17, 2018
- January 30, 2019 Amendment: Amended Response to October 24, 2018, FDA Advice and Information Request Letter (.zip – 5 MB) posted February 1, 2019
* These ZIP files include several individual files. Depending on your Internet connection speed and other factors, it may take a few minutes or up to several hours to download a ZIP file completely.
Note: We are required by section 911(e) of the Federal Food Drug & Cosmetic Act, as amended by the Tobacco Control Act, to make modified risk tobacco product (MRTP) applications available to the public (except for matters in the application that are trade secrets or otherwise confidential commercial information) and to request comments on the information contained in the applications and on the label, labeling, and advertising accompanying the applications. Please visit our Modified Risk Tobacco Products web page for more information.
- FDA Authorizes Modified Risk Tobacco Products
- October 22, 2019 – FDA grants first-ever modified risk orders to eight smokeless tobacco products
- Tobacco Products Scientific Advisory Committee: February 2019 Meeting Materials
- December 14, 2016 - FDA takes action on applications seeking to market modified risk tobacco products
- Perspective: Lessons Learned from the First Review of Modified Risk Tobacco Product (MRTP) Applications
- November 10, 2015 - FDA issues first product marketing orders through premarket tobacco application pathway
- Tobacco Product Scientific Advisory Committee (TPSAC) – April 2015 Meeting Materials
- TPSAC Meetings on MRTP Applications
- MRTP Overview